A Study to Assess the Safety and Effectiveness of Tacroli... | NCT00293891 | Trialant

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A Study to Assess the Safety and Effectiveness of Tacroli... | NCT00293891 | Trialant

Studies
A Study to Assess the Safety and Effectiveness of Tacrolimus Cream in the Treatment of Psoriasis

NCT00293891

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Dec 24, 2007Estimated

Enrollment

658Actual

Phase

Phase 3

Conditions

Psoriasis

Interventions

Tacrolimus Cream

Countries

United States
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

NCT00293891

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

04-0-206

Secondary IDs

Not provided

Brief Title

A Study to Assess the Safety and Effectiveness of Tacrolimus Cream in the Treatment of Psoriasis

Official Title

Not provided

Acronym

Not provided

Organization

Astellas Pharma IncINDUSTRY

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Jan 2007Actual

First Submitted Date

Feb 16, 2006

First Submission Date that Met QC Criteria

Feb 16, 2006

First Posted Date

Feb 20, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2007

Last Update Posted Date

Dec 24, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Astellas Pharma IncINDUSTRY

Collaborators

Name	Class
Astellas Pharma US, Inc.	INDUSTRY

Oversight Module

No data available

No data is available for this block.

Description Module

Brief Summary

A study to assess the safety and effectiveness of tacrolimus cream in the treatment of psoriasis.

Detailed Description

Not provided

Conditions Module

Conditions

Psoriasis

Keywords

Treatment Outcome
Tacrolimus
Safety
Psoriasis

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

658Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tacrolimus Cream	Drug

Outcomes Module

No data available

No data is available for this block.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of plaque psoriasis

Exclusion Criteria:

Skin disorder other than plaque psoriasis in the areas to be treated.
Disease on only elbows, knees, and scalp

Accepts Healthy Volunteers

No

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
J. Rico, MD	Astellas Pharma US, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama	35205	United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Randomized

Intervention Model

Parallel Assignment

Intervention Model Description

Not provided

Primary Purpose

Treatment

Observational Model

Not provided

Time Perspective

Not provided

Masking Info

Masking

Double

Masking Description

Not provided

Who Masked

Not provided

Little Rock

Arkansas

72205

United States

San Diego

California

92123

United States

Denver

Colorado

80246

United States

Miami

Florida

33144

United States

West Palm Beach

Florida

33407

United States

Newnan

Georgia

30263

United States

Indianapolis

Indiana

46256

United States

Louisville

Kentucky

40217

United States

North Andover

Massachusetts

01845

United States

Ann Arbor

Michigan

48109

United States

Port Huron

Michigan

48060

United States

St Louis

Missouri

63110

United States

Omaha

Nebraska

68144

United States

New York

New York

10032

United States

Durham

North Carolina

27710

United States

Columbus

Ohio

43212

United States

Dayton

Ohio

45408

United States

Portland

Oregon

United States

Knoxville

Tennessee

37917

United States

Dallas

Texas

75390

United States

Houston

Texas

77058

United States

San Antonio

Texas

78229

United States

Salt Lake City

Utah

84132

United States

Norfolk

Virginia

23507

United States

Seattle

Washington

98101

United States

Milwaukee

Wisconsin

53209

United States

Calgary

Alberta

T2S 3B3

Canada

Edmonton

Alberta

T5J 3S9

Canada

Surrey

British Columbia

V3R

Canada

Moncton

New Brunswick

E1C 8X3

Canada

Laval

Quebec

H7S 2C6

Canada

Montreal

Quebec

H2K 4L5

Canada

ID	Term
D011565	Psoriasis

Ancestor Terms

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided